Search Results for: CLINICAL TRIALS Its Time to
Articles
EXECUTIVE INTERVIEW - Yourway: Supporting COVID-19 Studies & Vaccine Distribution November 23, 2020
Leandro Moreira, Senior Vice President, Marketing and Business Development, Yourway, discusses what role the company will play in globally transporting COVID-19 vaccine(s), how Yourway is gearing up for this project, and the challenges of this extraordinary task.
Apellis Announces FDA Acceptance & Priority Review of NDA November 18, 2020
Apellis Pharmaceuticals, Inc. recently announced the US FDA has accepted and granted Priority Review designation for the New Drug Application (NDA)...Pfizer & BioNTech Reach Agreement to Supply the EU With 200 Million Doses of COVID-19 Vaccine November 11, 2020
Pfizer and BioNTech SE recently announced they have reached an agreement with the European Commission to supply 200 million doses of their investigational….
Castle Creek Biosciences Treats First Patient in Phase 1/2 Gene Therapy Trial October 22, 2020
Castle Creek Biosciences, Inc. recently announced that the first adult patient has been dosed in a Phase 1/2 clinical trial...MilliporeSigma’s New Platform Speeds Development of Cell & Gene Therapies October 14, 2020
MilliporeSigma has recently bolstered its viral vector manufacturing capabilities with the launch of its VirusExpress Lentiviral Production Platform…..
Scientific Management of Pharmaceutical Container Closure & Delivery Device Compatibility October 13, 2020
Diane Paskiet says the relationship between pharmaceutical products and CC/DD is best managed through a rich science-based approach that factors in potential risk and is adapted early in the development process.
PLATFORM TECHNOLOGY - Morphomer(TM) & SupraAntigen(TM) Platforms: Targeting Misfolded Proteins in Neurodegenerative Disorders October 1, 2020
Andrea Pfeifer, PhD, details the efforts to develop the therapeutic and diagnostic tools necessary to enable precision medicine approaches targeting the right protein, at the right time, in the right patient.
ASSAY DEVELOPMENT - Case Study: How Custom Assay Development Helped Spur Precision Medicine Research in Multiple Myeloma October 1, 2020
Steven Gross, MS, provides a behind-the-scenes look at the CMMC assay development process (from 2010 through today) to show how pharmaceutical companies can effectively partner with a laboratory to design customized assays that complement their drug discovery and development programs.
PEGYLATION - PEGylation - Three Decades of Product Approvals & Technology Development October 1, 2020
Esay Okutgen, PhD, Alper Orhan, MSc, and Josef Bossart, PhD, believe with the 30-year anniversary of the first product approval using PEG (polyethylene oxide polymer) conjugation, it seems an appropriate occasion to review the evolution of the technology (PEGylation) and subsequent product approvals.
CDMO CASE STUDY - AJILITY: Streamlining Drug Product Manufacturing October 1, 2020
Dustin Campbell says the AJILITY platform takes the burden off clients and allows his company to drive, manage, and support their drug product manufacturing, maximizing speed and success, while prioritizing these programs are driven to completion.
EXECUTIVE INTERVIEW - Immunic Therapeutics: Developing Next-Generation Oral Drugs in Chronic Inflammatory, Autoimmune & Infectious Diseases October 1, 2020
Daniel Vitt, PhD, Immunic’s Chief Executive Officer and President, discusses his company’s pipeline of selective, small molecule therapies aimed at treating chronic inflammatory and autoimmune diseases, and its recent progress.
DEVICE DEVELOPMENT - Designing Devices for Inhaled Drugs September 30, 2020
Andreas Meliniotis explains how there is plenty of opportunity for the development of new, improved devices to ensure inhaled drugs can be accessible for a wide range of patients and can treat various diseases and conditions effectively.
OSD FORMULATIONS - Dissolving Bioavailability & Solubility Challenges in Formulation & Development September 30, 2020
Vinod Patil, PhD, says many of the innovative and novel formulations introduced throughout the past decade have had to cope with poorly water-soluble APIs. Considering the pace of development, overcoming solubility issues will remain problematic, and this is especially true for important new classes of pharmaceuticals entering the market.
IMMUNOGENICITY TESTING - Regulatory Updates for Immunogenicity Assessment of Therapeutic Proteins September 30, 2020
Leon Shi, PhD, Lan Li, MS, and Jing Shi, PhD, provide a high-level analysis of the significant changes to the guidance compared to the immunogenicity draft guidance released in 2016, and the implications for drug development programs.
Orgenesis Announces Agreement to Acquire Koligo Therapeutics September 29, 2020
Orgenesis Inc. and Koligo Therapeutics, Inc. recently announced the two companies have entered into a definitive merger agreement, subject to final closing conditions, with expected completion….
TriNetX Acquired by Carlyle Group to Help Advance Health Research Optimization September 22, 2020
TriNetX recently announced global investment firm The Carlyle Group has made a strategic growth investment and will acquire a majority...Imanis Life Sciences Presents a First-in-Class Neutralizing Antibody Test for COVID-19 September 15, 2020
Imanis Life Sciences, LLC recently announced presentations about the development and validation of IMMUNO-COV, the first scalable, quantitative neutralizing antibody...Fortress Biotech Announces Initiation of Phase 3 Studies September 15, 2020
Fortress Biotech, Inc. recently announced that Caelum Biosciences, Inc., in collaboration with Alexion Pharmaceuticals, Inc., initiated the Cardiac Amyloid Reaching...RedHill Biopharma’s Opaganib Demonstrates Complete Inhibition of SARS-CoV-2 September 9, 2020
RedHill Biopharma Ltd. recently announced that opaganib demonstrated potent inhibition of SARS-CoV-2, the virus that causes COVID-19, achieving complete blockage of viral...SPECIAL FEATURE - Injection Devices: Will COVID-19 Deliver Growth to the Market? September 1, 2020
Contributor Cindy H. Dubin interviews several leading companies and highlights trends in autoinjectors, pen injectors, wearable devices and connectivity, and prefilled syringes.
